MacAulay BrownMedical Programs: Program Manager & Human Protection Assurance Officer
Aug. 2008 - Feb. 2013San Antonio, Texas AreaPerformed clinical/regulatory monitoring and auditing activities to ensure compliance of federal guidelines (GCP, GMP)
Developed training materials for researchers and support personnel addressing regulatory, quality assurance, and performance improvement related to clinical processes, clinical research submissions, IRB regulation adherence, and federal, state and local regulations
Expertise in the application and preparation of federal regulations (FDA, CDC, ICH, NIH) to clinical research protocols and pending IND submissions
Managed 25+ personnel in various capacities located across multiple states to include United States Army Institute for Surgical Research, Battlefield Health and Trauma Center, Wright Patterson Air Force Base 711th Human Protection Wing, etc.
Provided technical assistance with ICD-10 coding and data management training, program implementation, and manuscript/presentation preparations. Responsible for program forecasting, strategic planning/business development, and financials for corporate review/approval
Subcontracted epidemiology technical asst (author/editor) for Military Eye Trauma and Vision Restoration Research Comprehensive Program Plan (7 volumes). Project completed successfully Dec 2011